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Depression in AdolescenceTECH-ENCT05376358

Evaluation of MoodRing on Improving the Quality of Depression Management in Adolescents

A study testing MoodRing App in people with Depression in Adolescence, run by Ana Radovic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The MoodRing intervention is a mobile application for adolescents, parents, and an accompanying web-based clinician portal which enables adolescents to monitor their mood through the use of passively collected smartphone data. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Depression in Adolescence
What is being tested?
MoodRing App
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
12 May 2022to 20 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Adolescent:
  • age 12 -18
  • prior or present history of depression per self-report and/or clinician diagnosis
  • scores between 5 or higher on PHQ-9 consistent with at least mild symptoms of depression
  • read and understand English
  • has an Android or iOS smartphone compatible with AWARE mobile application and access to a smartphone data plan
Show all 14Show fewer
  • currently in United States
  • Parent/Guardian:
  • adolescent qualifies for study and assents to enroll
  • understands English
  • currently in United States
  • has a smartphone device that can download the intervention application
  • Healthcare Provider:
  • involved in providing mental health treatment (psychotherapy or antidepressant prescribing or making referrals) to adolescent participant - can be a primary care provider, therapist, subspecialist, psychiatrist

Who cannot join

  • Adolescent:
  • currently actively suicidal (have suicidal thoughts and plan with an intent to act on it)
  • plans to travel to countries belonging to the European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden), the United Kingdom (England, Scotland, Wales, and Northern Ireland), Norway, Iceland, or Lichtenstein in the next 6 months for more than 2 weeks at a time
  • Parent:
  • If their adolescent child is excluded
  • Healthcare Provider:
  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Adolescent and Young Adult Health

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Technology and Emotion Study "TECH-E": Randomized Controlled Trial of MoodRing Compared to Usual Care: Mobile Monitoring of Adolescent Depression Phase II

The MoodRing intervention is a mobile application for adolescents, parents, and an accompanying web-based clinician portal which enables adolescents to monitor their mood through the use of passively collected smartphone data. This randomized controlled trial will evaluate whether MoodRing as compared to usual care improves the quality of depression management.

Read the detailed description

This is a randomized controlled trial to evaluate the efficacy of MoodRing as compared to usual care for adolescents who have a prior diagnosis of depression. Adolescents with depressive symptoms, their parents, and their mental healthcare providers (if interested) will participate in a 6 month study. Adolescents age 12-18 and their parent will be consented for the study and be sent an online survey to obtain baseline measures. Those who complete the baseline measures will then be randomized to receive the MoodRing intervention or treatment as usual. Adolescents and parents will be asked to complete data collection at 3 months and 6 month time points post-randomization by online survey. Additionally, data will be collected for 3 and 6 month timepoints via the adolescent's electronic health record data. At 6 months, online surveys will be sent and an invitation to interview for patients' mental healthcare providers who consent to participate in the study.

Adolescent-parent dyads will be randomized at a 1:1 ratio (using randomized block sizes) to either 1) MoodRing or 2) usual care. 100 adolescent-parent dyads (200 total individuals) will be randomized to MoodRing and 100 adolescent-parent dyads (200 total individuals) will be randomized to usual care. We expect 50 clinicians will participate. In both arms, passively collected data will be obtained from adolescent smartphones as well as weekly mood surveys and monthly sleep surveys. In the 1) MoodRing arm adolescents will download the MoodRing-adolescent app, parents will download the MoodRing-parent app, and healthcare providers if interested will have access to a clinician dashboard. The randomization tables will be generated by the study statistician.

The investigators hypothesize that adolescents who receive MoodRing as compared to usual care will have:

H1: Improved self-management of depression as measured by change of baseline for the average score on the Partners in Health Scale

EH2: The investigators will also explore whether MoodRing as compared to usual care will result in improved quality of depression management as measured by frequency of symptom reassessment, medication adherence, and therapy adherence, less healthcare utilization, decreased depression symptoms, improved sleep quality, and increased application of self-management activities through increased self-efficacy, utilization of self-management skills and knowledge and social support.

H3: The investigators anticipate healthcare providers, adolescents, and parents will report satisfaction with use of MoodRing.

  • After date September 2022, we decided to make a change to the protocol and primary outcome. Due to recruitment challenges from mental health clinicians due to their clinical workload, we made a change to recruit adolescents directly including using social media. This introduced more heterogeneity to access to mental health care as well as less access to electronic health records systems that were external to our site which made it less likely to be able to measure quality of depression management. For this reason, the goal to recruit healthcare providers was discontinued. And the primary outcome was changed to self-management, changing our hypothesis to:

We hypothesized that MoodRing will help adolescents better self-manage their depression.

Secondary outcome measures were changed from "change in symptoms" to just that symptom total at 3 months and 6 months for better clinical interpretability.

Being tested
MoodRing App, Usual Care
Keywords
Adolescent, Adolescent Medicine, Mental Health Services, eHealth, Mobile Applications, Symptom Management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MoodRing AppDevice

    Adolescents and parents in the MR arm will receive instructions to download the MR app and AWARE app, customize the app, utilize an app-based self-guided onboarding, and review questions with the research team. The MR app provides the adolescent and their parent a notification to view a weekly report predicting their mood score (i.e. depression severity level similar to the Patient health questionnaire-9). The MR app will provide a library of coping strategies for adolescents and opportunities to self-track their mood.

    Clinicians in the MR Arm will get access to a MR portal online. They will be able to view patients they are a provider for. The clinician will receive in-person and/or video-based training to use the portal.

  • Usual CareOther

    Adolescents and parents in the usual care arm will receive instructions to download the AWARE app. This app will only track data and will not be interactive. Otherwise they will receive care as per routine by their healthcare provider team.

Study groups in NCT05376358
Study groupRoleWhat they receive
Usual CareActive comparatorParticipants in this arm will receive no intervention and access treatment as usual per their mental health services provider. A mobile application (AWARE) which is not interactive and is only for purposes of data collection will be downloaded on the adolescents' smartphone.
Receives: Other: Usual Care
MoodRingExperimentalAdolescent participants in this arm will download two mobile applications - a data collection non-interactive app to collect passive sensing data (AWARE) and the MoodRing (MR) mobile application with which they can visualize their data about their mood, sleep, activity, enter their own mood score, and access psychoeducational resources including links to a research-based website, SOVA. Their parents will download a parent MoodRing application which provides them with parenting resources and articles and a weekly report of their adolescents' mood as predicted by passive sensing. Clinical providers will receive access to a web portal where they can view their adolescent patients' data who are enrolled in the study.
Receives: Device: MoodRing App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Self-management at 3 Months

    Adolescents will be asked the Partners in Health Scale The revised Partners in Health Scale (Smith 2016) assesses self-management with respect to a chronic condition, with regard to active involvement of a patient in managing their condition. Total scores range from 0 to 96 with higher scores indicating worse self-management.

    A larger negative change in self-management score means an improvement in self-management.

    Measured: From baseline to 3 months

Secondary outcomes (21)
  1. Quality of Depression Management: Depression Symptom Reassessment

    Attendance at a healthcare provider visit for depression symptom reassessment within 3 months (yes/no) measured by adolescent or parent self-report (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.

    Measured: 3 months

  2. Quality of Depression Management: Medication Adherence

    Out of adolescents who are taking an antidepressant, receipt of at least 60 consecutive days (yes/no) measured by adolescent self-report. The metric reported will be percentage of individuals per study arm with a 'yes' result.

    Measured: 3 months

  3. Quality of Depression Management: Therapy Adherence

    Out of adolescents who report being referred for psychotherapy, receipt of at least 3 sessions within 3 months (yes/no) measured by adolescent and parent self-report (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.

    Measured: 3 months

  4. Healthcare Utilization for Acute Care or Primary Care (for Non Mental-health Reason)

    Average Number of visits for (greater number as reported by adolescent self-report and parent self-report):

    1. urgent care;
    2. emergency room;
    3. inpatient hospitalization;
    4. acute primary care provider visit for non-mental health related concern;
    5. medical subspecialist visit
    6. surgical subspecialist visit

    Measured: 3 month

  5. Depression Severity at 3 Months

    Adolescents will be asked the PHQ-9 Patient Health Questionnaire-9 measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.

    Measured: 3 months

  6. Sleep-Related Impairment at 3 Months

    Adolescents will respond to the PROMIS Pediatric Sleep-Related Impairment scale. This scale has four questions with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 19 with higher scores indicating higher levels of sleep-related impairment.

    Measured: 3 months

  7. Sleep Disturbance at 3 Months

    Adolescents will respond to the PROMIS Pediatric Sleep Disturbance scale. This scale has four questions, the second (sleeping through the night) being reverse-scored, with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 20 with higher scores indicating higher levels of sleep disturbance.

    Measured: 3 months

  8. Self-Efficacy at 3 Months

    Adolescents will be asked the Mental Health Self-efficacy Scale (MHSES) The Mental Health Self-efficacy Scale (Clarke, 2014) measures one's belief in one's capability to perform mental health self-care behaviors. The score ranges from 6 to 60, with higher scores indicating higher confidence in mental health selfcare.

    Measured: 3 months

  9. Self-management Behavior at 3 Months

    Adolescents will be asked based on Question 12 of Partners in Health Scale about self-management behavior. This question asks the average amount of time (options including Daily, More than once a week, Once a week, Once a month, Once a semester, Once a year, Less than once a year, Never) spent in potentially useful self-management activities. Each time category will be described by a percentage. Each of the following are asked individually: (1) created to-do lists to help me focus; (2) found strategies to create pleasurable distractions; (3) engaged in some physical activity (cycling, walking, etc.); (4) set realistic short-term goals; (5) made sure I had a good day/night routine with got enough sleep; (6) ensured enough rest to avoid getting exhausted; (7) left the house regularly; (8) ate healthy

    A higher score indicates a better outcome.

    Measured: 3 months

  10. Social Support at 3 Months

    Adolescents will be asked the Medical Outcomes Study Social Support Survey The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. Each item ranges from 1 to 5 and the total score is averaged and ranges from 1 to 5, with higher levels associated with greater support.

    Measured: 3 months

  11. Change in Self-management at 6 Months

    Adolescents will be asked the Partners in Health Scale The revised Partners in Health Scale (Smith 2016) assesses self-management with respect to a chronic condition, with regard to active involvement of a patient in managing their condition. Total scores range from 0 to 96 with higher scores indicating worse self-management.

    A larger negative change in self-management score means an improvement in self-management.

    Measured: From baseline to 6 months

  12. Quality of Depression Management: Depression Symptom Reassessment

    Attendance at a healthcare provider visit for depression symptom reassessment within the past 3 months (yes/no) measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.

    Measured: 6 months

  13. Quality of Depression Management: Medication Adherence

    Out of adolescents who are taking an antidepressant, receipt of at least 60 consecutive days (yes/no) within the past 3 months, measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.

    Measured: 6 months

  14. Quality of Depression Management: Therapy Adherence

    Out of adolescents who are referred for psychotherapy, receipt of at least 3 sessions within the past 3 months (yes/no) measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.

    Measured: 6 months

  15. Healthcare Utilization for Acute Care or Primary Care (for Non Mental-health Reason)

    Number of visits for (combined total between adolescent self-report, parent self-report, and electronic health-record review):

    1. urgent care;
    2. emergency room;
    3. inpatient hospitalization;
    4. acute primary care provider visit for non-mental health related concern;
    5. medical or surgical subspecialist visit

    Measured: 6 month

  16. Depression Severity at 6 Months

    Adolescents will be asked the PHQ-9 Patient Health Questionnaire-9 measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.

    Measured: 6 months

  17. Self-management Behavior at 6 Months

    Adolescents will be asked based on Question 12 of Partners in Health Scale about self-management behavior. This question asks the average amount of time (options including Daily, More than once a week, Once a week, Once a month, Once a semester, Once a year, Less than once a year, Never) spent in potentially useful self-management activities. Each of the following are asked individually: (1) created to-do lists to help me focus; (2) found strategies to create pleasurable distractions; (3) engaged in some physical activity (cycling, walking, etc.); (4) set realistic short-term goals; (5) made sure I had a good day/night routine with got enough sleep; (6) ensured enough rest to avoid getting exhausted; (7) left the house regularly; (8) ate healthy

    Measured: 6 months

  18. Self-Efficacy at 6 Months

    Adolescents will be asked the Mental Health Self-efficacy Scale (MHSES) The Mental Health Self-efficacy Scale (Clarke, 2014) measures one's belief in one's capability to perform mental health self-care behaviors. The score ranges from 6 to 60, with higher scores indicating higher confidence in mental health selfcare.

    Measured: 6 months

  19. Social Support at 6 Months

    Adolescents will be asked the Medical Outcomes Study Social Support Survey The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. Each item ranges from 1 to 5 and the total score is averaged and ranges from 1 to 5, with higher levels associated with greater support.

    Measured: 6 months

  20. Sleep-Related Impairment at 6 Months

    Adolescents will respond to the PROMIS Pediatric Sleep-Related Impairment scale. This scale has four questions with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 19 with higher scores indicating higher levels of sleep-related impairment.

    Measured: 6 months

  21. Sleep Disturbance at 6 Months

    Adolescents will respond to the PROMIS Pediatric Sleep Disturbance scale. This scale has four questions, the second (sleeping through the night) being reverse-scored, with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 20 with higher scores indicating higher levels of sleep disturbance.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start12 May 2022
  3. Primary completion27 Mar 2024
  4. Study completion20 Jun 2024

Why it stopped: The study was terminated prior to being able to recruit the full sample due to lack of funding and expiration of time on the award. The sample recruited completed the entire 6 month study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will use a parallel study design, where participants are randomized into two intervention groups (Usual Care or MoodRing) and will receive interventions in parallel.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05376358
Sponsor's protocol ID
STUDY21050120
Other IDs
R44MH122067
Acronym
TECH-E
Status last verified
Jul 2025
First submitted
11 May 2022
Last updated
14 Aug 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Trial outcome data can be accessed by contacting the study principal investigator. Otherwise there is currently no formal plan for data sharing.

Questions about this trial

What is this clinical trial studying?

A study testing MoodRing App in people with Depression in Adolescence, run by Ana Radovic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Self-management at 3 Months (time frame: From baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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